Class 2 Device Recall VNS Therapy AspireHC Pulse Generator

• Date Initiated by Firm: November 20, 2014
• Date Posted: December 23, 2014
• Recall Status: Terminated on February 08, 2016
• Recall Number: Z-0858-2015
• Recall Event ID: 69844
• PMA Number: P970003
• Product Classification: Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
• Product: Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
• Code Information: Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
• Recalling Firm/ Manufacturer: Cyberonics, Inc; 100 Cyberonics Blvd; Houston TX 77058-2069
• For Additional Information Contact: 281-228-7200
• Manufacturer Reason for Recall: The recalled product was distributed with an incorrect serial number printed on the device's label.
• FDA Determined Cause: Labeling mix-ups
• Action: The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
• Quantity in Commerce: 1 unit
• Distribution: Distributed to PA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LYJ